Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)

Phase 2 Completed 242 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin (MK-0431/ONO-5435) used once daily (qd) in Japanese participants with impaired glucose tolerance who have inadequate glycemic control using diet and exercise therapy.

Timeline

Start: 2011-08-16
Primary completion: 2012-04-09
Completion: 2012-04-09

Outcome

Met primary endpoint

registry analysis (other test); Placebo vs Sitagliptin 25 mg; p <0.001; Difference in Least Squares Means -7.11 (95% CI -9.85 to -4.36); Constrained Longitudinal Data Analysis NCT01405911 ↗

registry analysis (other test); Placebo vs Sitagliptin 50 mg; p <0.001; Difference in Least Squares Means -9.08 (95% CI -11.82 to -6.33); Constrained Longitudinal Data Analysis NCT01405911 ↗

Publications

Background Kaku K, Kadowaki T, Terauchi Y, Okamoto T, Sato A, Okuyama K, Arjona Ferreira JC, Goldstein BJ. Sitagliptin improves glycaemic excursion after a meal or after an oral glucose load in Japanese subjects with impaired glucose tolerance. Diabetes Obes Metab. 2015 Nov;17(11):1033-41. doi: 10.1111/dom.12507. Epub 2015 Jul 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sitagliptin	Small molecule	25 mg	Oral
Subject	Sitagliptin	Small molecule	50 mg	Oral